Study to Find the Best Dose of Tirapazamine with Embolization for Liver Cancer
Sponsor: Teclison Ltd.
ClinicalTrials ID:NCT02174549
This clinical trial is testing the best dose and safety of a drug called tirapazamine when used with a procedure called embolization to treat liver cancer. The study is open to patients with certain types of liver cancer, including those with neuroendocrine tumors that have spread to the liver.
Patient Parameters
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Program Overview
This study aims to find the best dose and safety of a drug called tirapazamine when used with embolization, a procedure that blocks blood flow to liver tumors. Patients with liver cancer who have a Child-Pugh score of A and no more than four tumors are eligible. Tirapazamine is given directly into the liver's blood supply before embolization. The treatment's effect is checked using MRI scans. If the cancer progresses, the treatment may be repeated. The study has completed the initial phase of testing different doses and is now focusing on patients with neuroendocrine tumors that have spread to the liver.
Description
The study uses a method called 3+3 design to find the best dose of tirapazamine. Groups of 3 to 6 patients receive increasing doses until the highest safe dose is found. Embolization is done using standard methods with materials like Lipiodol and Gelfoam, guided by X-ray. Once the best dose is found, a larger group of 15 patients will receive this dose to see how well it works. The study includes patients with liver cancer, metastatic tumors that have spread to the liver, and neuroendocrine tumors. Side effects are monitored using standard criteria, and the treatment's effectiveness is checked with MRI scans. The initial phase of testing different doses is complete, and the study is now enrolling patients with neuroendocrine tumors for further testing.
Eligibility Criteria
Inclusion Criteria
- Have well-differentiated neuroendocrine tumors (NET) with liver-dominant spread and growing liver tumors, regardless of where the original tumor started.
- Can have tumors outside the liver, but most of the cancer must be in the liver.
- No limit on the size or number of liver tumors, but they must not take up more than 50% of the liver.
- Can have had previous treatments approved by the FDA, like medications, surgery, or other liver-targeted therapies.
- Must be 20 years or older, in good general health, and have no major heart, lung, or kidney problems.
- Must be suitable for certain liver procedures (TAE or TACE) and have no blockage in the portal vein.
- Must have specific blood counts and liver and kidney function within set limits.
- Women who can become pregnant must use effective birth control during the study and for 6 months after the last dose. Men with partners who can become pregnant must use effective birth control during the study and for 3 months after the last dose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Stanford University | 94305 | Palo Alto | California |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
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